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Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584948
First Posted: January 2, 2008
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Aging (NIA)
Forest Laboratories
Information provided by (Responsible Party):
University of California, Davis
December 22, 2007
January 2, 2008
June 27, 2014
April 10, 2017
May 30, 2017
September 2007
September 2012   (Final data collection date for primary outcome measure)
  • Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II) [ Time Frame: One Year ]
    The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance.
  • Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale [ Time Frame: 1 year ]
    The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2
Improvement in neurocognitive functioning [ Time Frame: One Year ]
Complete list of historical versions of study NCT00584948 on ClinicalTrials.gov Archive Site
Not Provided
Improvement in Cognitive ERP Deficits [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome
Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine
The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fragile X-Associated Tremor/Ataxia Syndrome
  • Fragile X Premutation Carriers
  • Drug: Memantine
    Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
    Other Name: Namenda
  • Drug: Placebo
    Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
  • Experimental: Memantine
    Intervention: Drug: Memantine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Seritan AL, Nguyen DV, Mu Y, Tassone F, Bourgeois JA, Schneider A, Cogswell JB, Cook KR, Leehey MA, Grigsby J, Olichney JM, Adams PE, Legg W, Zhang L, Hagerman PJ, Hagerman RJ. Memantine for fragile X-associated tremor/ataxia syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Mar;75(3):264-71. doi: 10.4088/JCP.13m08546.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5

Exclusion Criteria:

  • Previous reaction to memantine
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00584948
200715426-1
1RL1AG032115-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of California, Davis
University of California, Davis
  • National Institute on Aging (NIA)
  • Forest Laboratories
Principal Investigator: Randi J Hagerman, MD University of California, Davis
University of California, Davis
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP